An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 5 mg
Overview
- Phase
- Phase 3
- Intervention
- Telmisartan + amlodipine
- Conditions
- Hypertension
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 309
- Locations
- 30
- Primary Endpoint
- Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Telmisartan+amlodipine+HCTZ
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
Intervention: Telmisartan + amlodipine
Telmisartan+amlodipine+HCTZ
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
Intervention: hydrochlorothiazide
Telmisartan+amlodipine
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Intervention: Telmisartan + amlodipine
Telmisartan+amlodipine
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Time Frame: baseline and week 8
Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
Secondary Outcomes
- Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.(baseline and week 8)
- The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period(baseline and week 8)